(24 days)
Currently commercialized Hologic® QDR® X-Ray Bone Densitometers
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No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard software evolution and operating systems, with no mention of AI/ML specific features or training/test data.
No.
The device's intended use is estimation of Bone Mineral Density (BMD) and Bone Mineral Content (BMC), which are diagnostic measurements, not therapeutic interventions.
Yes
The device is intended for the "estimation of BMD" using X-ray bone densitometers, which is a key measurement in diagnosing conditions like osteoporosis.
No
The device is described as software that operates with a specific hardware device (Hologic QDR X-Ray Bone Densitometers) and is an evolution of software currently shipping with those devices. It does not appear to be a standalone software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The Eagle software for Hologic QDR X-Ray Bone Densitometers estimates bone mineral density (BMD) and bone mineral content (BMC) using X-ray imaging. This is a non-invasive measurement performed directly on the patient's body, not on a sample taken from the body.
- Input: The input is X-ray data, not a biological sample.
Therefore, the device falls under the category of medical imaging software used for diagnostic purposes, but it is not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the Eagle software for the Hologic QDR X-Ray Bone Densitometers is estimation of BMD.
The intended use of the Hologic Eagle Software Option is to estimate the projected bone mineral density (BMD, in g/cm2) and the Bone Mineral Content (BMC, in g) at various anatomical sites using the Hologic QDR® X-Ray Bone Densitometers.
Product codes
90 KGI
Device Description
The Eagle software operates with the Microsoft® Windows® 98 operating system and is a direct evolution from the software that is currently shipping with the QDR X-ray bone densitometers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
X-Ray
Anatomical Site
various anatomical sites
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Currently commercialized Hologic® QDR® X-Ray Bone Densitometers
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1170 Bone densitometer.
(a)
Identification. A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or gamma ray transmission measurements through the bone and adjacent tissues. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Specical 510(K) - SUMMARY
Eagle Software for the HOLOGIC® QDR® X-Ray Bone Densitometers
| Submitter Name: | Hologic, Incorporated |
|---|---|
| Submitter Address: | 35 Crosby Drive |
| Bedford, MA 01730 | |
| Contact Person: | Nandini Murthy, Regulatory Scientist |
| Phone Number: | (781) 999-7300 |
| Fax Number: | (781) 280-0662 |
| Date Prepared: | August 9, 1999 |
| Device Trade Name: | Eagle software for Hologic® QDR® X-Ray Bone |
| Densitometers | |
| Device Common Name: | X-Ray Bone Densitometer |
| Predicate Device: | Currently commercialized Hologic® QDR® X-Ray Bone |
| Densitometers | |
| Device Description: | The Eagle software operates with the Microsoft® Windows® 98 |
| operating system and is a direct evolution from the software that | |
| is currently shipping with the QDR X-ray bone densitometers. | |
| Intended Use: | The intended use of the Eagle software for the Hologic QDR |
| X-Ray Bone Densitometers is estimation of BMD. |
- BMD = Bone Mineral Density
0012
1
ന 1999 SEP :
Ms. Nandini Murthy Regulatory Scientist Hologic, Inc. 35 Crosby Drive Bedford. MA 01730
Dear Ms. Murthy
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K992677 Eagle Software for Hologic® QDR® X-Ray Bone Densitometers Dated: August 9, 1999 Received: August 10, 1999 Product Code: 90 KGI Regulatory Class: II (two) 21 CFR 892.1170
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been redassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
BART D. U.S. Saito, M.D.
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement
The intended use of the Hologic Eagle Software Option is to estimate the projected bone mineral density (BMD, in g/cm2) and the Bone Mineral Content (BMC, in g) at various anatomical sites using the Hologic QDR® X-Ray Bone Densitometers.
Yamil h. Sezon
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Dev, 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
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